- Physicians Office Resource

The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
VITEK® REVEAL™ SEALER - 900-00003

Device Description

A mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: SAN

Device Name: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

Device Class: 2

Physical State: In vitro diagnostic device

Definition: Automated system that performs antimicrobial susceptibility testing using positive blood culture samples

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Antimicrobial susceptibility testing of microbes detected in positive blood cultures

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: For antimicrobial susceptibility testing using positive blood cultures

Regulation Number: 866.1650

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 00860007326912

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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